Principal Scientist, Drug Substance

Role Summary

The Principal Scientist of Drug Substance provides technical leadership for late-stage product development, process optimization, and manufacturing to support Phase 3 and registration activities for Akebia’s praliciguat program. Responsibilities include identifying critical process parameters, process scale-up and technical transfers, and overseeing contract drug substance manufacturing sites. The role ensures timely delivery of drug substance supplies for research, non-clinical and clinical activities, and supports deviation/investigation, change controls, and authoring/review of protocols, reports, and relevant sections of IND/IMPD and NDA/MAA.

Responsibilities

• Provide technical and tactical leadership for phase-appropriate execution of drug substance strategies to support development, optimization, scale-up, and manufacturing of praliciguat drug substance.
• Lead Praliciguat CMC drug substance Project Team; oversee project milestones, drive activities with team members, manage timelines, contracts, invoices, and be responsible for project deliverables.
• Assist functional and senior CMC leadership to develop risk-based strategies for process development and commercial activities, including route scouting, registration, validation, and clinical/commercial manufacturing.
• Assist in identification and characterization of process impurities; provide technical rationale for impurity structures and routes of formation.
• Author/review and approve technical protocols, reports, and batch records.
• Oversee and manage activities at contract manufacturing organizations (CMOs); ensure timely production of drug substance inventory with robust compliance to Akebia processes, procedures, and regulatory requirements.
• Use statistical tools to develop process understanding, analyze data to establish critical process parameters and in-process controls, and identify process improvements.
• Foster a collaborative team environment for cross-functional problem solving and decision-making.
• Support regulatory submissions by writing and reviewing drug substance–related sections.
• Travel up to 25% of the time domestically; some international travel may be required.

Qualifications

• Bachelor’s, Master’s, or Ph.D. Degree in Organic Chemistry, Biochemistry, Chemical Engineering or a related discipline
• 10+ years of relevant experience
• Experience in small molecule chemical process development, technology transfer and oversight of activities at external partners
• Direct experience in managing activities at contract development and manufacturing organizations
• Advanced writing skills required; ability to draft protocols, technical reports, impact assessments, process justification reports, policies and procedures
• Ability to review and approve clinical/commercial batch records and extract relevant data for analysis and trending
• Experience with review and approval of commercial process validation documentation: validation plan, manufacturing stage specific protocols, validation reports
• Experience with the use of statistical tools (preferred)
• Experience supporting registration and validation activities, including impurities fate/purge assessments, identification and setting of critical process parameters and in-process controls, monitoring of additional key process parameters, and writing/reviewing/approving protocols and reports; manufacturing oversight
• Ability and desire to work in a fast-paced, start-up environment
• Effective time management, sound judgment, and ethical conduct
• Working knowledge of ICH guidelines, GMPs, and global regulatory requirements
• Strong collaboration, team-building, and communication skills

Education

• As listed under Qualifications: Bachelor’s, Master’s, or Ph.D. in relevant scientific field

Additional Requirements

• Up to 25% domestic travel; some international travel may be required